DELIVER II Registry - DELIVER II Registry

Description:

The goal of the DELIVER II registry trial was to identify factors that lead to an increased risk of target lesion revascularization (TLR) in patients with complex coronary lesions implanted with the paclitaxel nonpolymeric ACHIEVE stent.

Study Design

Study Design:

Patients Enrolled: 1,533 patients; 1986 lesions treated
Mean Follow Up: All patients six months; 500 patients through one year
Mean Patient Age: Mean age 61.7 years
Female: 22

Patient Populations:

Complex lesions treated with the paclitaxel nonpolymeric-coated ACHIEVE™ Drug-Eluting Coronary Stent System

Exclusions:

More than one lesion in the same vessel; more than two lesions to be treated; or prior drug-eluting stent

Primary Endpoints:

TLR at six months

Secondary Endpoints:

TVF at six months; MACE at 30 days, six months, and one year; device success; and procedure success

Drug/Procedures Used:

Patients with complex coronary lesions treated with the paclitaxel nonpolymeric-coated ACHIEVE™ Drug-Eluting Coronary Stent System were enrolled in the DELIVER II registry from 86 sites in Europe, the Middle East, and Africa. All patients were followed for clinical events for six months, and a subset of 500 patients will be followed for one year.

Principal Findings:

Mean number of lesions treated per patient was 1.3, and 71.6% were de novo lesions. Complex lesion characteristics included restenotic in 28.5%, chronic or subtotal occlusion in 16.5%, small lesions (<2.75 mm) in 55.2%, long lesions in 16.7%, and bifurcation lesions in 29.0%. Target vessel was the left anterior descending (LAD) in 48% of lesions.

In a per lesion analysis, the primary endpoint of TLR occurred in 10.5% of lesions by six months (8.8% TLR with percutaneous coronary intervention [PCI] and 2.5% TLR with coronary artery bypass graft). In a per patient analysis, the six-month major adverse cardiac event (MACE) rate was 15.7%, target vessel failure (TVF) 16.7%, mortality 2.3%, Q-wave myocardial infarction (MI) 2.3%, and non-Q wave MI 2.6%.

Risk factors for TLR at six months on multivariate analysis included postprocedure minimum lumen diameter (MLD), LAD lesions, number of diseased vessels, restenotic lesions, and total stent length. Diabetes was not identified as a risk factor for TLR at six months.

Interpretation:

Among patients with complex coronary lesions implanted with the paclitaxel nonpolymeric ACHIEVE stent, postprocedure MLD, LAD lesions, number of diseased vessels, restenotic lesions, and total stent length were identified as risk factors for TLR at six months.

Because the trial was a registry, it was not designed to assess the efficacy of the paclitaxel nonpolymeric ACHIEVE stent since there was no control group. The DELIVER trial did evaluate efficacy and demonstrated that the ACHIEVE stent was not associated with a significant reduction in TVF or angiographic binary restenosis compared with control. Given the lack of efficacy in the DELIVER trial, it is unclear if the risk factors would be applicable to the more widely used polymeric coated stents, which other trials have shown to be efficacious in preventing TLR.

References:

Presented by Eberhard Grube at the European Society of Cardiology Congress, Vienna, Austria, September 2003.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery

Keywords: Paclitaxel, Myocardial Infarction, Multivariate Analysis, Risk Factors, Coronary Artery Bypass, Diabetes Mellitus, Stents, Percutaneous Coronary Intervention


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